According to data generated by the Center of Disease Control in 2005, as found in the center for disease control website (www.cdc.gov/nchs/fastats/delivery.htm) approximately twenty-five percent of live births are reported to be cesarean sections. This data results in over 600,000 U.S. women incurring a cesarean section scar each year. The predominant surgical approach for a cesarean section is a lower transverse uterine incision, resulting in a “bikini line” incision and scar of four to eight inches in length in the peri-pubic area.
Scar tissue is the known result of the human body's healing process. This process is relatively well understood and broken down into three general phases; 1) inflammatory phase where blood flow changes and phagocytosis occur, 2) proliferative phase where tissue granulation and wound closure occur and 3) maturation or remodeling phase where new collagen formation. The three phases combined are considered to last up to or may even be longer than two years. The end result of the healing process is closed and sealed skin at the incision site which functions to resist infections and provide protection for the deeper tissues. Unfortunately, this end result generally forms a visible scar which is considered aesthetically undesirable to many individuals. Scars are also known to be unlike normal skin tissue and have the concerns of hypersensitivity, erythema (redness) and pruritus (itching) as well as the cosmetic concerns of being bulky and raised.
As discussed in sufficient detail in the medical journal Burns “Silicones in the Rehabilitation of Burns; a Review and Overview, 2001 (27); 205-214, the treatment of scars has long been considered a factor in burn rehabilitation and that specialty has been at the forefront of techniques to understand and ameliorate the condition of scar tissue.
Non-invasive treatment of scarring in burn rehabilitation largely comprises the techniques of pressure and application of medicament (e.g. silicone) dressings. Pressure is thought to influence the “organization” of the newly deposited collagen fibers as well as decrease tension on the wound by displacing it to the periphery of the compression. Pressure, as used in the remediation of burn and hand scarring, is often applied by custom-made elastic garments. Silicone, or occlusive dressings, control the moisture content of the developing scar tissue and also apply pressure and decrease wound tension. Along with the usual and preferred silicone medicaments, other occlusive or semi-occlusive medicament dressings that control scar moisture have also been mentioned in the literature. These two techniques are used either in conjunction or alone extensively in burn rehabilitation. The specialties of reconstructive surgery, especially on the hands and face, and dermatology have incorporated the use of these post-burn techniques into treatment modalities as well as explored their efficacy as demonstrated in the literature, for example, in the journal Clinical Plastic Surgery, Pressure Techniques for the Prevention of Hypertrophic Scar, 1992, July; 19(3):733-743 and the journal Dermatology Surgery, Silicone Gel Sheeting for the Prevention and Management of Evolving Hypertrophic and Keloid Scars, 1995, November; 21(11):947-951. As demonstrated in the literature, the use of compression and silicone or occlusive dressing is well documented to improve scar hypersensitivity, color, pruritus, size, volume and density.
There currently is no product that integrates the use of scar management techniques for the cesarean incision site. There is also no undergarment that utilizes purely peri-pubic compression designed to specifically address cesarean incisions and other low transverse incisions.